Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1898-2021 | Class II | VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F... | Bard Peripheral Vascular Inc | QAN | |
| Z-1897-2021 | Class II | VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F... | Bard Peripheral Vascular Inc | QAN | |
| Z-1107-2021 | Class II | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of... | Phadia AB | LSW | |
| Z-0959-2021 | Class II | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x... | Prytime Medical Devices, Inc. | OFC | |
| Z-0931-2021 | Class II | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON... | K2M, Inc | NKG | |
| Z-0934-2021 | Class II | Neuroreader Medical Image Processing Software - Product Usage: intended to automate the... | Brainreader | LLZ | |
| Z-0725-2021 | Class II | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the... | Integra LifeSciences Corporation | JXG | |
| Z-0724-2021 | Class II | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the... | Integra LifeSciences Corporation | JXG | |
| Z-0918-2021 | Class II | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for... | FUJIFILM Healthcare Americas Corporation | LLZ | |
| Z-0937-2021 | Class II | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast... | Qiagen | OWD | |
| Z-0770-2021 | Class II | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide... | Ortho-Clinical Diagnostics, Inc. | JHS | |
| Z-0876-2021 | Class II | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in... | STERIS Corporation | MEC | |
| Z-0807-2021 | Class II | VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic... | Baxter Healthcare Corporation | FTM | |
| Z-1101-2021 | Class II | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System... | GE Healthcare | JAA | |
| Z-1134-2021 | Class II | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated... | Sentec AG | LKD | |
| Z-0858-2021 | Class II | Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear... | GE Healthcare | KPS | |
| Z-0857-2021 | Class II | Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670... | GE Healthcare | KPS | |
| Z-0856-2021 | Class II | Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber... | GE Healthcare | KPS | |
| Z-0855-2021 | Class II | GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general... | GE Healthcare | KPS | |
| Z-0854-2021 | Class II | GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear... | GE Healthcare | KPS | |
| Z-0853-2021 | Class II | GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear... | GE Healthcare | KPS | |
| Z-0769-2021 | Class II | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 | Remel Inc | JSI | |
| Z-1077-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA... | Argon Medical Devices, Inc | DYB | |
| Z-1076-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA... | Argon Medical Devices, Inc | DYB | |
| Z-1075-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA... | Argon Medical Devices, Inc | DYB | |
| Z-1074-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA... | Argon Medical Devices, Inc | DYB | |
| Z-1073-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA... | Argon Medical Devices, Inc | DYB | |
| Z-1072-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA... | Argon Medical Devices, Inc | DYB | |
| Z-0785-2021 | Class II | TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated... | Accuray Incorporated | IYE | |
| Z-0784-2021 | Class II | TomoTherapy Treatment System - Product Usage: used as an integrated system for the... | Accuray Incorporated | IYE | |
| Z-0808-2021 | Class II | Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count)... | Acucon | LPL | |
| Z-0949-2021 | Class II | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24... | Riverpoint Medical, LLC | GAM | |
| Z-0924-2021 | Class II | BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of... | Becton Dickinson & Co | N/A | |
| Z-0923-2021 | Class II | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of... | Becton Dickinson & Co | N/A | |
| Z-0152-2022 | Class II | smiths medical portex Loss of Resistance Device, REF 100/398/000 | Abbott Medical | BSP | |
| Z-1271-2021 | Class II | Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table... | Canon Medical Systems USA, Inc. | MQB | |
| Z-1270-2021 | Class II | Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table... | Canon Medical Systems USA, Inc. | OWB | |
| Z-1269-2021 | Class II | Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table... | Canon Medical Systems USA, Inc. | OWB | |
| Z-0869-2021 | Class II | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage... | Magstim Inc. | ETN | |
| Z-0727-2021 | Class II | ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system | Philips North America LLC | OWB | |
| Z-0740-2021 | Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in... | Medtronic Neurosurgery | JXG | |
| Z-0739-2021 | Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in... | Medtronic Neurosurgery | JXG | |
| Z-0738-2021 | Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in... | Medtronic Neurosurgery | JXG | |
| Z-0755-2021 | Class II | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801... | Roche Diagnostics GmbH | JJE | |
| Z-0754-2021 | Class II | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701... | Roche Diagnostics GmbH | JJE | |
| Z-0766-2021 | Class II | BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of... | Becton Dickinson & Co | LON | |
| Z-0765-2021 | Class II | BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of... | Becton Dickinson & Co | LON | |
| Z-0764-2021 | Class II | BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of... | Becton Dickinson & Co | LON | |
| Z-0763-2021 | Class II | BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of... | Becton Dickinson & Co | LON | |
| Z-0762-2021 | Class II | BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of... | Becton Dickinson & Co | LON |